Because Roche rigged the game by designing and conducting a clinical trial that made the traditional cervical cancer screen – the pap test – look less safe than it actually is. Using this false standard for comparison made the risks of the new way of using the HPV test appear to be equal with those of the pap test. A misleading study doesn’t get the FDA off the hook for this decision, however. The agency accepted flawed research and a corporate pitch for innovation instead of applying the rigorous evaluation standards that women expect from the regulatory agency charged with ensuring the safety and effectiveness of the medical products we use.

Cervical cancer screening is a vital part of the reproductive health services a woman needs over her lifetime. The pap test, which has been in use for decades, has almost entirely eliminated cervical cancer for women who have reliable access to health care. When screening is overused, however, it can pose its own threat to women’s health. Women who are over-screened are far more likely to be subjected to false alarms and additional, more invasive testing, with its own health risks. Current cervical cancer screening guidelines established by independent medical experts at the U.S. Preventive Services Task Force (USPSTF) give women and health care providers information about who to screen, how often, and the evidence (or lack of evidence) supporting the available tests.

But now the FDA has approved a new use for the HPV test that establishes the option of using it alone to screen for cervical cancer in women 25 years and older, instead of using the pap test. This is not in line with expert guidelines and could result in a shift away from evidence-based healthcare that would negatively affect millions of women for the majority of their adult lives. Conveniently for Roche, that shift would also mean increased use of the more expensive HPV test, sales that will go directly into Roche’s coffers. At the Network, we believe that evidence should drive the services offered and the information available to women – not potential industry profit!

New Use of the HPV Test Departs From Evidence-Based Guidelines

To explain how new use of the HPV test goes against evidence-based healthcare, I first have to explain what is done now. In addition to the USPSTF guidelines, mentioned above, it is also worth noting that neither the Centers for Disease Control and Prevention, the American Congress of Obstetrics and Gynecology, the American Cancer Society, nor the American Association of Family Practitioners has recommended HPV testing as a first-line screening tool in any patient population. In fact, the USPSTF guidelines recommend women between the ages of 21 and 65 should be screened for cervical cancer every three years using a pap test. Additionally, the guidelines warn that there is not sufficient evidence to recommend use of the HPV test as a primary screening tool for cervical cancer.

Despite medical consensus supporting these guidelines, Roche proposed and the FDA approved use of the HPV test alone to screen for cervical cancer in women age 25 and older. This goes against evidence-based medical practice by allowing the HPV test to be used alone even though it can result in overtreatment and serious harm to women.

New Use of the HPV Test Poses a Threat to Women’s Health

Excessive screening for HPV poses a danger to women because it will lead to unnecessary use of invasive follow-up procedures, such as colposcopy and cervical biopsy, which can cause vaginal bleeding, pain and infection, and for women who later become pregnant can increase the risk of preterm delivery, low birth weight in infants and perinatal death. The Network is extremely concerned that if clinicians begin to use the HPV test alone to screen for cervical cancer, as the FDA has told them they can and as Roche will undoubtedly encourage them to do, that it will increase the number of unnecessary colposcopies and biopsies performed, resulting in significant harm to women.

We are particularly concerned about the impact of HPV testing alone on younger women, who are more likely to test positive for HPV. Although HPV infection is common, especially in younger women, it often resolves without intervention, and when that happens it does not increase the risk of developing cervical cancer. Consequently, use of the HPV test in younger women would likely lead to unnecessary and harmful treatment of HPV infections that would have gone away. Furthermore, replacing the pap test with the HPV test could actually reduce the effectiveness of cervical cancer screening because the HPV test only detects HPV, whereas the pap test can also identify signs of pre-malignancy and cancers – both those caused by HPV and those with other causes.

New Use of the HPV Test Is Based on Misleading Study Results

The trial that Roche submitted to the FDA compared the HPV test alone to the pap test alone, which is a good comparison, except that in the trial any woman with an abnormal pap test was sent immediately to get a colposcopy, which is not what happens in the real world. Current guidelines recommend that a woman with an abnormal pap wait a year to see if it resolves on its own or get an HPV test to confirm before getting a colposcopy. Because of the flawed protocol in the pap test group, the trial results showed that the pap test sent as many women to colposcopy as the HPV test; however, if the trial had mimicked current practice, the HPV test would likely have sent many more women to colposcopy than the pap test.

The Network vigorously advocates for drugs and medical devices to be approved based on evidence. Furthermore, we strongly support recommendations for use of health products and services that provide women and providers with information that allows them to accurately weigh the benefits and risks of their health care decisions. Until there is adequate evidence to determine whether use of the HPV test alone in women 25 and older reduces the risk of developing cervical cancer and does not subject younger women to unnecessary harm from overtreatment, we are opposed to this new use of the HPV test.